The presence of undeclared pharmaceutical ingredients in products purporting to be dietary supplements is garnering an increasing amount of attention and enforcement from the Food and Drug Administration, databases compiled by the American Herbal Products Association show.

AHPA maintains a number of databases that compile entries on enforcement actions, New Dietary Ingredients notifications and other data sets. In the field of weight loss enforcement actions and sexual enhancement products, mining AHPA’s data reveals some interesting trends.

AHPA and other stakeholders have long called for increased enforcement by FDA of the laws governing dietary supplements. At least in terms of these tainted products that masquerade as dietary supplements, that seems to be happening.

AHPA has compiled databases on two high risk categories: Weight loss products and sexual enhancement products. Both categories are rife with products that contain undeclared active pharmaceutical ingredients. In the weight loss category, the primary adulterant is sibutramine, a presciption appetite suppressant that was taken off the market in 2010 over health concerns. In the sexual enhancement area, the undeclared ingredients of concern are various analogues of sildenafil (Viagra) or knock-off versions of other erectile dysfunction drugs. In both categories other undeclared ingredients of concern may be involved.

Rising tide of enforcement

The database shows some interesting trends. In weight loss, there have been 14 enforcement actions in the past three months (May 15 to August 15). This compares to 13 actions in the same period a year previously. Year to date in 2014, there have been 38 enforcement actions compared to 18 in the same period in 2013. On a whole year basis, in 2010, FTC took 16 enforcement actions concerning weight loss products, 6 in 2011 and 13 in 2012. For all of 2013, there were 46 actions.

For sexual enhancement enforcement actions, the picture was similar. In the past three months, FTC has taken 14 enforcement actions, compared to 16 in the same period in 2013. Year to date, there have been 23 actions concerning sex products, compared to 33 for the same period a year earlier. For whole year totals, the sexual enhancement enforcement picture looked like this: 19 actions in 2010, 10 in 2011, 21 in 21 in 2012, and 46 actions for all of 2013.

Taken together, these data present jagged lines on a graph, but with clear upward trends and in the case of weight loss, an accelerating trend.

The types of enforcment actions varied. The most common is an apparently quick and dirty apporach called a ‘public notifcation.’ In this case, the agency warns the public of that the products contain undeclared pharmaceutical and gives consumers the contact information of the agency. Many of the instances that are dealt with in this way appear to be small lot type products, many packaged in single serving blister packs, such as this sex product branded as O.M.G.

In other cases, companies choose to work with FDA to issue voluntary recalls. For example, in April a company called Bacai Inc. recalled its LifeFit weight loss product that FDA said contained sibutramine
.

Repeat offenders

Sibutramine isn’t the only ingredient of concern in the weight loss category. Recently a company called Regeneca issued a recall on its RegeneSlim weight loss product
, though in this case the product contained DMAA, not sibutramine. Regenca appears to be a repeat offender on these lists. The company received a warning letter from FDA in September 2012 over the DMAA content in RegeneSlim
. In May, 2011, the company received a warning letter from FDA concerning its RegenErect product
, which the agency said contained a sildenafil analogue. Regeneca recalled the product at that time and also recalled a similar product called RegenArouse, in that case for the inclusion of tadalafil (sold under the brand name Cialis). Yet despite the warning letter and previous recalls, in February 2012, the company recalled two products bearing the same names. Both now contained tadalafil, according to FDA. The lists may well contain other repeat offenders, too, but getting definitive information on these types of companies can be difficult, as some marketers put out products under multiple brand names and aliases.

McGuffin didn’t equivocate when it comes what he thinks ought to be done with repeat offenders.

“Our position is that FDA should use its full enforcement authority. Certainly on repeat offenders, and the second time is sufficient repeating for me, the agency ought to go to the maximum enforcement possible,” he said.

Question of nomenclature

What to call these renegade products has been a bone of contention between industry and FDA for a number of years. McGuffin said he wonders why FDA doesn’t just call them ‘illegal drugs,’ though he admitted that might raise hackles among pharmaceutical manufacturers, who could rightly complain (just as ethical dietary supplement companies do) that these products are not representative of the business practices of companies that comply with GMPs, whether for drugs or dietary supplements.

After years of back and forth with the regulators, McGuffin said he has seen some movement, but more could be done. He cited at least one government website that still bundles such products under the aegis of dietary supplements.

“I think FDA could do a better job of clearly communicating that these are not dietary supplements. These are illegal drugs masquerading under the trade dress of dietary supplements. I’m comfortable with calling them ‘tainted products,’ ” he said.

The nomenclature question is important, McGuffin said, because if these products are called ‘tainted dietary supplements,’ this could bolster the position of those who claim the sector is insufficiently regulated.

“I want to be clear that this is in no manner a problem caused by DSHEA,” he said.

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The presence of undeclared pharmaceutical ingredients in products purporting to be dietary supplements is garnering an increasing amount of attention and enforcement from the Food and Drug Administration, databases compiled by the American Herbal Products Association show.

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